Are Clones Really Unstable?

  • Kriti Shukla
  • Saravanan Desan
  • Ankur BhatnagarEmail author
  • Anuj Goel
Conference paper
Part of the ESACT Proceedings book series (ESACT, volume 5)


Selection of a stable clone is one of the most essential criteria for the successful production of any therapeutic protein. The stability of the clone needs to be evaluated in terms of various parameters like cell growth, specific cell productivity (PCD) and product characteristics with increasing generations. To generate sufficient amount of inoculum for the production bioreactor, cells from cell bank are periodically sub-cultured which in turn increases the generation number. Thus the clone needs to be stable for multiple generation numbers. In this study a stability programme has been designed which is based on the use of a scale down model of inoculum generation and the manufacturing process. The stability of the clones also showed a correlation with the diameter of the cells during sequential passaging. It was shown that choice of appropriate medium used for cell passaging make these clones stable.


Cell Diameter Stability Programme External Environmental Condition Specific Cell Productivity Production Bioreactor 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Nor. Xv

normalized viable cell count

Nor. IgG

normalized product concentration


picogram of product formed/cell/day (specific productivity)


specific growth rate (1/h)

G. no.

generation number


gene copy index number



Janani, Ruchika, Sunaina, Chandrashekhar, VanaRaja, Biswamohan and Ashita for their contribution in cell culture, analytical and characterization results.


  1. Janet Chusainow, et al. (2008). A Study of Monoclonal Antibody- Producing CHO Cell Lines: What Makes a Stable High Producer? Biotechnology and Bioengineering, 102, 1182–1196.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2012

Authors and Affiliations

  • Kriti Shukla
    • 1
  • Saravanan Desan
    • 1
  • Ankur Bhatnagar
    • 1
    Email author
  • Anuj Goel
    • 1
  1. 1.Biocon LimitedBangaloreIndia

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